deltatrials
Completed EARLY_PHASE1 INTERVENTIONAL 3-arm NCT00047983

Omega-3 Fatty Acids That Affect the Immune System in Kidney Transplant Patients

A Randomized Trial of Immunomodulating Diets With Arginine and Omega-3 Fatty Acids in Renal Transplant Recipients

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Updated 7 times since 2017 Last updated: Jan 10, 2017 Completion: Apr 30, 2004
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A EARLY_PHASE1 clinical study on Kidney Diseases, this trial is completed. The trial is conducted by National Institute of Allergy and Infectious Diseases (NIAID) and has accumulated 7 data snapshots since 2026. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Study Description(click to expand)

Short-term survival rates of donor tissue after kidney transplantation have improved significantly in recent years because of improved immunosuppression. Rates of long-term tissue loss have changed less because of a high incidence of chronic rejection, infectious complications, and cardiovascular disease. Data suggest that both early and late complications might be reduced in transplant recipients by dietary intervention to raise levels of omega-3 fatty acids and arginine. Prior to transplantation, participants are randomized to one of three groups. Group 1 participants serve as controls and receive no dietary supplements. Participants in Group 2 receive daily nutritional supplements of arginine and canola oil according to body weight. Group 3 participants receive daily nutritional supplements of arginine and a fish oil emulsion according to body weight. All participants receive a standard, low-fat dietary consultation. The status of participants is evaluated peri-transplant and at 1, 3, 6, and 9 months.

Short-term survival rates of donor tissue after kidney transplantation have improved significantly in recent years because of improved immunosuppression. Rates of long-term tissue loss have changed less because of a high incidence of chronic rejection, infectious complications, and cardiovascular disease. Data suggest that both early and late complications might be reduced in transplant recipients by dietary intervention to raise levels of omega-3 fatty acids and arginine.

Prior to transplantation, participants are randomized to one of three groups. Group 1 participants serve as controls and receive no dietary supplements. Participants in Group 2 receive daily nutritional supplements of arginine and canola oil according to body weight. Group 3 participants receive daily nutritional supplements of arginine and a fish oil emulsion according to body weight. All participants receive a standard, low-fat dietary consultation. The status of participants is evaluated peri-transplant and at 1, 3, 6, and 9 months.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotCompleted~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – present · 7 months · monthly snapshotCompleted

Change History

7 versions recorded
  1. Sep 2025 — Present [monthly]

    Completed EARLY_PHASE1

  2. Sep 2024 — Sep 2025 [monthly]

    Completed EARLY_PHASE1

  3. Jul 2024 — Sep 2024 [monthly]

    Completed EARLY_PHASE1

  4. Jan 2021 — Jul 2024 [monthly]

    Completed EARLY_PHASE1

  5. Jun 2018 — Jan 2021 [monthly]

    Completed EARLY_PHASE1

Show 2 earlier versions
  1. Feb 2017 — Jun 2018 [monthly]

    Completed EARLY_PHASE1

    Phase: Phase 0EARLY_PHASE1

  2. Jan 2017 — Feb 2017 [monthly]

    Completed Phase 0

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • National Institute of Allergy and Infectious Diseases (NIAID)
Data source: National Institute of Allergy and Infectious Diseases (NIAID)

For direct contact, visit the study record on ClinicalTrials.gov .